Pre-operative sleep promotion as prehabilitation to prevent post-operative delirium in the elderly (Brief: Sleep and Delirium) - Subarea I - Intervention, Subarea II - Patients' perspective and evaluatio

Not Applicable

Conditions: F51.0
G47.0
Nonorganic insomnia
Disorders of initiating and maintaining sleep [insomnias]

Registration Number: DRKS00027143

Lead Sponsor: Evangelisches Klinikum Bethel Universitätsklinikum OWL Abteilung für Gerontopsychiatrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 20

Inclusion Criteria

Age: over 65 years and older
- Patients who have an indication for an inpatient operation of any kind, and
- who have an expected interval between the indication and the admission for surgery of at least four weeks.
- Subjects with a sleep disorder with the following criteria:
- Difficulty falling asleep or staying asleep or poor sleep quality occurring at least 3x/week for a period of at least one month.
- There is excessive preoccupation with the sleep disorder at night and during the day and excessive worry about its negative consequences.
- The unsatisfactory sleep duration or quality either causes significant distress or has a disruptive effect on daily activities.
- The sleep disorder is seen as a diagnosis in its own right, even though it may be a symptom of another mental disorder or physical illness (such as pain or discomfort due to an underlying orthopedic condition, for example)

Exclusion Criteria

- Severe physical comorbidity where life expectancy is likely to be less than three months.
- severe cognitive impairment
- Evidence of untreated sleep apnea syndrome.
- Evidence of untreated restless legs syndrome, periodic limb movement syndrome, or delayed sleep phase syndrome
- bipolar disorder
- untreated addictive disorders
- driving heavy machinery or regular, long car trips

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acceptance, tolerability<br>- Qualitative, semi-standardized interview after completion of the intervention<br>- Acceptance and tolerability is noted during the implementation of the intervention<br>- treatment satisfaction (adapted version of ZUF-8)<br>- Drop-out rate during the sleep promotion intervention (with reasons)<br>Sleep quality<br>Before-after change in sleep-related paramaters:<br>- Pittsburgh Sleep Quality Index (PSQI, Buysse et al., 1991)<br>- Insomnia Severity Index (ISI, Morin, C.M. 1993)<br>- Sleep efficiency (SE), sleep quality, total sleep time (TST), latency to fall asleep (SOL), ability to sleep through the night (WASO) determined using a sleep diary (Müller & Paterok, 2010)<br>Delirium incidence<br>Peri-operative delirium incidence up to the 7th post-operative day or previous discharge using established delirium screening instruments such as ICDSC, NuDESC, 4AT

Secondary Outcome Measures

Name	Time	Method
pre-post change in the following paramaters:<br>- Number and type of sedatives taken<br>- daytime sleepiness (Eppworth Sleepiness Scale, Johns, 1991)<br>- Pain questionnaire (FESV)<br>- Motor function by means of non-invasive digital 3-D video analysis of the movement or gait sequence